Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors

Baycrest

Status: Unknown

Conditions: Stroke Risk; Ischemic White Matter Disease; Transient Ischemic Attack; Mild Stroke

Treatments: Behavioral: Executive Function Training Program; Behavioral: Psychoeducational Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01951612

08-53

232-2009 (Other Identifier)

Details and patient eligibility

About

Stroke is a leading cause of disability; most strokes (80%) are subcortical, with ischemic damage due to occlusion in penetrating arteries. Although ischemic white matter disease (iWMD) may lack gross clinical manifestation, it causes significant cognitive impairment, particularly on measures of executive function, attention, and memory. This impairment is attributable to diffuse damage affecting network connections.

While there are many studies concerning rehabilitation of motor function and language in patients with large focal strokes, few studies have addressed attentional and executive functions. To our knowledge, there are no such studies on iWMD. In this study, patients will be randomized to a novel intervention for improving executive function and a control condition matched for therapist exposure. Patients will be assessed pre-intervention, post-intervention, and at long-term follow-up using a battery of behavioural and neuroimaging tasks. We predict that the novel intervention will be associated with improved executive function, as assessed behaviourally, and improved frontal network function, as assessed through neuroimaging markers.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ischemic white matter disease or small vessel disease, who have experienced a transient ischemic attack, mild stroke, or are at risk of stroke
• Fluent in English
• Able to provide informed consent to all procedures
• Sufficient motor and sensory functioning to complete all study components (with correction or assistance as required)

Exclusion criteria

• Substance abuse
• Other psychiatric condition (other than mood, personality, or behaviour change following onset/diagnosis of white matter disease or related condition mentioned above)
• Other medical condition suspected to influence cognition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Executive Function Training Program

Experimental group

Description:

Participants in this group will receive the novel intervention training.

Treatment:

Behavioral: Executive Function Training Program

Psychoeducational Training Program

Active Comparator group

Description:

Participants in this group will receive the control intervention training.

Treatment:

Behavioral: Psychoeducational Training Program